Real-world Clinical Response to Trazodone in Italy, Poland, and Romania

Angelini Pharma

Status: Enrolling

Conditions: Cognition Disorders in Old Age; Depression - Major Depressive Disorder

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07377682

039(Z)MD24063

Details and patient eligibility

About

TRACOMDD study is a study with the intention to describe the real-world use of trazodone and the clinical response in a sub-group of patients affected by Major Depressive Disorder and Mild Cognitive impairment, by collecting data from standard clinical practice in Italy, Poland, and Romania

Enrollment: 120 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 55 or older.
• Patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD diagnosis.
• Patients experiencing a current major depressive episode of at least moderate severity, defined by a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥20 at enrolment.
• Patients with a diagnosis of MCI (also referred to as "mild neurocognitive disorder") according to the DSM-5 criteria.
• Patients who start treatment with trazodone hydrochloride (prolonged release) with starting dosage according to SmPC at enrolment visit (or at latest within one week).
• Patients legally capable of giving their written consent to participate in the study (including personal data processing) and willing to comply with all study procedures as per clinical judgement.

Exclusion criteria

• Patients who meet any of the contraindications to the administration of trazodone according to the approved local SmPC.
• Known hypersensitivity or allergy to the active ingredient and/or to any component of the study medication.
• Concomitant treatment with other antidepressant drugs, mood stabilizers, antipsychotics, and/or proved resistance to trazodone monotherapy.
• Patients with current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, severe personality disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition.
• Patients with previous or current history of any neurological condition that, in the opinion of the Investigator, might compromise participation in the study.
• Patients participating in any interventional study in the 30 days prior to the enrolment visit.
• Patients with ongoing pregnancy or breast-feeding at enrolment visit.